annex 9 guidelines on packaging for pharmaceutical products

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There are also no published guidelines for appropriate dosing regimens and duration of treatment The FDA has not approved any injectable products for skin lightening Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver kidneys and

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3 Table of contents Item Page 1 Introduction 4 2 Scope 5 3 Products Subject for Pharmaceutical Products Regulation Office Classification 5 3 1 Product subject to registration with PPR 6 3 1 1 Medicine 6 3 1 2 Health product 7 3 1 2 1 Herbal product 7 3 1 2 2 Combination product (Herbal/Vitamin and Mineral/Others) 8 3 1 2 3 Others 8 3 1 3 Alternative and complementary medicine 10 3 2 Product

Good Cold Chain Management forTemperature

Guidelines on Good Cold Chain Management for Temperature Sensitive Pharmaceutical Products–Annex 1– 2015 5/17 1 Containers containers labeling 1 1 Any controlled transport and/or storage conditions as well as warning statements (for example Time and Temperature Sensitive Do Not Freeze) should be clearly stated on the label applied to shipping containers This label should be

Authors: Kathryn Lawson

The quality of pharmaceutical packaging can have a significant impact on the performance of pharmaceutical products and can reduce shelf-life if the improper packaging is used Packaging must:1 • Protect against all adverse external influences (e g moisture light oxygen and temperature variation) which may affect quality or potency of the product • Protect against biological

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MCAZ Registration Guidelines Published Jan 2012 DRAFT FOR COMMENTS Page 1 of 79 Medicines Control Authority of Zimbabwe 1 GUIDELINE ON SUBMISSION OF DOCUMENTATION FOR 2 REGISTRATION OF A MULTISOURCE (GENERIC) FINISHED 3 PHARMACEUTICAL PRODUCT (FPP): QUALITY PART IN 4 THE COMMON TECHNICAL DOCUMENT (CTD) FORMAT 5 6 7 Please

9 7 Annex G Evidence summary 3

9 7 Annex G Evidence summary 3 – Application of cost-plus pricing formulae for pharmaceutical products Note: This Annex replicates the evidence summary prepared in October 2011 with textual and presentational modifications for publication purposes Topic: Cost-plus pricing is a method for setting retail prices of medicines by taking into account production cost of a medicine together with

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List of ICH Quality Guidelines in Pharmaceuticals Annex 4C(R1) – Microbiological Examination of Non-Sterile Products : Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical use General Chapter Q4B – Annex 5(R1) – Disintegration Test General Chapter Q4B Annex 6 (R1) – Uniformity of Dosage Units General Chapter Q4B Annex 7(R2) – Dissolution Test

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4 1 Guidelines for the stability testing of pharmaceutical products containing established drug substances: 4 2 Joint WHO/UNICEF study on the quality of selected drugs at the point of use in developing countries: 5 Good manufacturing practices for pharmaceutical products: 5 1 Adoption of additional guidelines: 5 2 Further guidance on good

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annex 8 sampling of starting and packaging materials 146 annex 9 manufacture of liquids creams and ointments 148 annex 10 manufacture of pressurised metered dose aerosol preparations for inhalation 149 annex 11 computerised systems 151 annex 12 use of ionising radiation in the manufacture of medicinal products 155 annex 13 manufacture of investigational medicinal

WHO Expert Committee on Specifications for

4 1 Guidelines for the stability testing of pharmaceutical products containing established drug substances: 4 2 Joint WHO/UNICEF study on the quality of selected drugs at the point of use in developing countries: 5 Good manufacturing practices for pharmaceutical products: 5 1 Adoption of additional guidelines: 5 2 Further guidance on good

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PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A SITE MASTER FILE Based on World Health Organization WHO Technical Report Series No 961 2011 Annex 14 WHO guidelines for drafting a site master file Page 2 of 9 1 Introduction 1 1 The site master file (SMF) is prepared by the pharmaceutical manufacturer and should contain specific information about the quality

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Good Distribution Practices for Pharmaceutical Products Doc No : INS/GDL/002 This document lays down guidelines for the distribution of pharmaceutical products These guidelines shall apply equally to products for human and for veterinary use The guidelines thus cover products for which a prescription is required by the patient products which may be provided to a patient without a

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Introduced on 16 April 2014 the European Union clinical trial regulation No 536/20141–2 is expected to be implemented by October 2018 1 2 One of its most significant changes is found in Annex VI which covers the labeling requirements for authorized and unauthorized investigational medicinal products (IMPs) and auxiliary medicinal products used in EU clinical trials

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20 AVENUE APPIA – CH-1211 GENEVA 27 – SWITZERLAND – TEL CENTRAL +41 22 791 2111 – FAX CENTRAL +41 22 791 3111 – WWW WHO INT Piramal Healthcare UK – Desk Assessment - API 12 September 2019 This inspection report is the property of the WHO Contact: prequalinspectionwhot

New Guidance for Sterile Products Manufacture is

Pharmaceutical Quality System The first main section of the draft refers to the Pharmaceutical Quality System a quality system that each manufacturer should have in place While general matters are covered in Chapter 1 of EU GMP the draft Annex makes reference to specific aspects for sterile products manufacture These include:

Cold Chain Platform

WHO Good Distribution Practices for Pharmaceutical Products WHO Technical Report Series No 957 2010 Annex 5: WHO: 2010 : WHO Guide to good storage practices for pharmaceuticals WHO Technical Report Series No 908 2003 Annex 9: WHO: 2003 : GMP (Good Manufacturing Practice) Title Publisher Issue Date Files EMA ICH Q7 Good manufacturing practice for active pharmaceutical

Annex 9 Guidelines on packaging for pharmaceutical products

Annex 9 Guidelines on packaging for pharmaceutical products Introductory note 120 Glossary 121 1 Aspects of packaging 125 1 1 General considerations 125 1 2 Functions of packaging 127 1 2 1 Containment 127 1 2 2 Protection 127 1 3 Presentation and information 129 1 3 1 Labels 129 1 3 2 Repacking relabelling and dispensing 130

Good Cold Chain Management for Temperature

Guidelines on Good Cold Chain Management for Temperature Sensitive Pharmaceutical Products – Edition 2 – 2017 3/17 Introduction In order to maintain product quality safety and efficacy during distribution Good Distribution and Storage Practices specify that temperature-sensitive products are to be stored handled and distributed carefully throughout the distribution network

WHO Expert Committee on Specifications for

Good manufacturing practices for sterile pharmaceutical products: 5 3 Guidelines for good storage practices : 5 4 Hazard analysis and critical control point system: 6 Quality assurance - inspection: 6 1 Pre-approval inspections: 6 2 Quality systems for national GMP inspectorates: 7 Quality assurance - packaging: 7 1 General aspects of packaging: 7 2 Glass containers for pharmaceutical

Annex 9 Model guidance for the storage and transport of

Annex 9 Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products Abbreviations Background Key to conventions used Glossary Introduction Key to conventions used 1 Importation 1 1 Port handling and customs clearance 1 1 1 Port of entry 1 1 2 Offl oading 1 1 3 Temporary storage at port of entry

GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA

GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA NATIONAL PHARMACEUTICAL REGULATORY AGENCY MINISTRY OF HEALTH MALAYSIA 1st Revision – February 2017 Please visit the NPRA website for the latest updates Address: Lot 36 Jalan Universiti 46200 Petaling Jaya Selangor Darul Ehsan Malaysia +603-7883 5400 +603-7956 2924

List of ICH Quality Guidelines in Pharmaceuticals

List of ICH Quality Guidelines in Pharmaceuticals Annex 4C(R1) – Microbiological Examination of Non-Sterile Products : Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical use General Chapter Q4B – Annex 5(R1) – Disintegration Test General Chapter Q4B Annex 6 (R1) – Uniformity of Dosage Units General Chapter Q4B Annex 7(R2) – Dissolution Test

Annex 3 WHO good manufacturing practices for

Annex 3 WHO good manufacturing practices for pharmaceutical products: main principles Introduction General considerations Glossary Quality management in the medicines industry: philosophy and essential elements 1 Quality assurance Product quality review 2 Good manufacturing practices for pharmaceutical products 3 Sanitation and hygiene 4 Qualifi cation and validation 5 Complaints 6

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